Comparison of Radial Extracorporeal Shock Wave Therapy Application Protocols for Lower-Limb Spasticity: A Prospective Crossover Study

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1030260210

Enrollment

Registered

2026-06-10

Start date

2026-06-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke spasticity post-stroke, spasticity

Interventions

The key feature of the intervention in this study is that the application protocols of radial extracorporeal shock wave therapy (rESWT) including the application sites and treatment areas are delibera

D012867

Radial Extracorporeal Shock Wave Therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with post-stroke spasticity in the chronic phase (over 6 months after stroke onset) Plantar flexor spasticity of the ankle with a Modified Ashworth Scale (MAS) score of 1+ to 3 are excluded Age between 18 and 74 years Patients clinically indicated for radial extracorporeal shock wave therapy (rESWT) and who have provided written informed consent for study participation

Exclusion criteria

Exclusion criteria: atients with contraindications to radial extracorporeal shock wave therapy (rESWT), including but not limited to the presence of a pacemaker, bleeding tendency, or malignancy Patients with severe ankle joint contracture that makes reliable measurement using iQMoS difficult Patients with severe cognitive impairment that makes it difficult to obtain written informed consent Patients with a history of surgery or significant trauma to the measurement site (lower leg) Patients with MAS score of 4 (due to the risk of unreliable measurements)

Design outcomes

Primary

Measure	Time frame
Comparison of Temporal Changes and Change Rates in Ankle Dorsiflexion Resistance Measured Using iQMoS	—

Secondary

Measure	Time frame
Assessments at Each Measurement Time Point The following assessments are performed at each measurement time point Modified Ashworth Scale Modified Tardieu Scale Passive range of motion of the ankle joint Clinical Information Collected at Baseline At the initiation of treatment, the following clinical information is collected from medical records Medical history, age, sex, and primary diagnosis Past medical history Clinical examination data, including Blood tests Brain magnetic resonance imaging Cerebral angiography Xray imaging InBody body composition analysis Functional Independence Measure Fugl Meyer Assessment Brunnstrom Recovery Stage 3 minutes walk test Timed Up and Go test Treatment history, including prior botulinum toxin therapy, physical therapy, and rehabilitation interventions	—

Measure

Time frame

Assessments at Each Measurement Time Point The following assessments are performed at each measurement time point Modified Ashworth Scale Modified Tardieu Scale Passive range of motion of the ankle joint Clinical Information Collected at Baseline At the initiation of treatment, the following clinical information is collected from medical records Medical history, age, sex, and primary diagnosis Past medical history Clinical examination data, including Blood tests Brain magnetic resonance imaging Cerebral angiography Xray imaging InBody body composition analysis Functional Independence Measure Fugl Meyer Assessment Brunnstrom Recovery Stage 3 minutes walk test Timed Up and Go test Treatment history, including prior botulinum toxin therapy, physical therapy, and rehabilitation interventions

—

Contacts

Public ContactMiyuki Matsumoto

Showa Medical University

miyukimats@med.showa-u.ac.jp+81-8088383282

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026